TeleHealth Resources for IndiVidualizEd Goals (THRIVE) in Alcohol Recovery Study

NCT06074341 | Active Not Recruiting DMC

• 2 other identifiers: 2212028742R01AA031159
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 1

Brief Summary

This project will evaluate the effectiveness and mechanisms of mindfulness-based relapse prevention (MBRP) delivered via video conferencing, as compared to referral to online mutual support groups, in supporting long-term whole-person recovery and improvements in neurobiologically-informed domains of addiction among individuals with alcohol use disorder who are interested in reducing or stopping drinking. The project will also examine the reach, effectiveness, adoption, implementation, and maintenance of MBRP as an accessible and freely available continuing care option that supports long-term recovery from alcohol use disorder in all communities nationwide, including medically underserved and health professional shortage areas.

Conditions

Alcohol-Related Disorders; Alcohol Use Disorder; Alcohol Drinking

Keywords

mindfulness; recovery; mutual help; harm reduction

Outcome Measures

Primary Outcomes (1)

• Recovery from AUD

  Recovery is a binary (yes/no) outcome defined by achieving all three of the following: (1) Remission from Diagnostic and Statistical Manual, 5th edition alcohol use disorder (AUD) based on an 11-item AUD symptom checklist (endorsing 0 or 1 item is AUD remission); (2) Cessation of heavy drinking (defined as not engaging in heavy drinking over the past 28 days with heavy drinking defined as 4 or more drinks per occasion for females, and 5 or more drinks per occasion for males, measured by the Timeline Follow-Back); and (3) Improvements in functioning and well-being as measured by higher score on the World Health Organization Quality of Life domain scores (each of 26 items scored from 1 to 5 on a response scale, which are then transformed linearly to a 0-100-scale) and the 36-item Short Form Health Survey Mental Health Component Score (scored on a 0-100 scale). Recovery is achieved if remission, cessation of heavy drinking, and improvements in functioning and well-being are achieved.

  Change from baseline to three year follow-up period

Secondary Outcomes (15)

• Reduction in World Health Organization risk drinking levels

  Change from baseline to three year follow-up period

• PROMIS Alcohol Negative Consequences

  Change from baseline to three year follow-up period

• PROMIS Preference Score (PROPr)

  Change from baseline to three year follow-up period

• Penn Alcohol Craving Scale

  Change from baseline to three year follow-up period

• Alcohol Use Disorder symptoms

  Change from baseline to three year follow-up period

Study Arms (2)

Mindfulness-based relapse prevention

EXPERIMENTAL

The MBRP condition will be based on an existing rolling group treatment manual, which consists of eight 60-minute sessions. Each session will begin with a brief mindfulness practice and a discussion of "what is mindfulness?" and the role mindfulness may play in recovery. The themes are repeated every eight sessions, but in every session the participant is bringing a new direct moment experience to the practices in that session. The groups will also consist of people in various stages of recovery and familiarity with the material, which can make for richer discussions of the material led by the group members themselves. Participants who are randomized to receive rolling MBRP treatment will also have access to the Thrive Recovery smart phone app, which includes audio-guided MBRP meditations for participants to practice in daily life.

Behavioral: Mindfulness-based relapse prevention

Referral to online mutual support groups

ACTIVE COMPARATOR

The referral group will consist of a brief 1:1 meeting with a research team member who will provide an orientation to online mutual support and discuss the SMART Recovery, Alcoholics Anonymous (AA), and other virtual meeting options and to discuss how to access mutual support via these platforms. Individuals will also have an opportunity to review the process of attending online groups, and will discuss technology issues that might arise during groups. The session will be 20-30 minutes in length.

Behavioral: Online Mutual Support Groups

Interventions

Online Mutual Support Groups BEHAVIORAL

Mutual support groups are free, peer-led organizations that are designed to help individuals with substance use disorders and other addiction-related problems. Mutual support groups often focus on communication and exchange of addiction and recovery experience and skills. Individuals participate in activities that engage, educate, and support patients recovering from substance use disorder from others facing similar challenges. Mutual help organizations that will be offered as referrals include: Alcoholics Anonymous (AA), In The Rooms, and SMART Recovery.

Referral to online mutual support groups

Mindfulness-based relapse prevention BEHAVIORAL

Mindfulness-based relapse prevention (MBRP) is a group-based treatment to provide individuals with skills intended to foster increased awareness of triggers, destructive habitual patterns, and "automatic" reactions to triggering experiences. Mindfulness practices in MBRP are designed to help individuals pause, observe present experience, and bring awareness to the range of choices available in every moment. Through MBRP individuals learn to respond in ways that serve them, rather than react in ways that are detrimental to their health and happiness.

Mindfulness-based relapse prevention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• Received AUD treatment or made a self-change attempt to reduce or stop drinking in the past 3 months or is interested in reducing or stopping drinking
• Meet criteria for a current AUD
• Engaged in heavy drinking (more than 14 standard drinks per week or more than 4 drinks on a single day for men and more than 7 drinks per week or more than 3 drinks on a single day for women) in the past 6-months
• Able to understand all study procedures and able to consent in English or Spanish.
• Be willing to use a personal smart phone or tablet that is connected to the internet, or being willing to use a study-provided tablet
• Have access to a valid U.S. mailing address for receiving dried blood spot card or blood collection device.

You may not qualify if:

• Current symptoms of psychosis or mania.
• Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (1)

• Kirouac M, Otero DS, Moniz-Lewis DIK, Bowen S, Roos CR, Vinci C, Vasquez AR, McCool M, Schwebel FJ, Chavez R, Martinez A, Quintana R, Olson R, Witkiewitz K. Telehealth-Delivered Mindfulness-Based Intervention: Protocol for a Randomized Clinical Trial for Individuals with Alcohol Use Disorder. JMIR Res Protoc. 2026 Mar 9. doi: 10.2196/92198. Online ahead of print.

  PMID: 41818691 DERIVED

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking; Alcohol-Related Disorders; Harm Reduction

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Study Officials

• Katie Witkiewitz

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 10, 2023
• Study Start: September 13, 2023
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the time of publication of the primary manuscript, or within 12 months of last patient assessment.
• Access Criteria: Implementation of the plan will follow the NIAAA Data Archive and Data Sharing Policy

Locations

US (1)